DelfaGLP-1 Atlas

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RecruitingPhase 2

A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight

Phase 2b Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety and Tolerability of Maridebart Cafraglutide in Adult Participants Living With Elevated Liver Fat and Obesity or Overweight

Lead sponsor

Amgen

Asset

Maridebart cafraglutide / MariTide

Subcutaneous · GLP-1 agonist / GIP antagonist

Listed sites

21

Recruiting sites

21

Enrollment

180

estimated

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight

Key I/E criteria

•BMI 27-40•HbA1c ≤9.5%

Primary endpoints

•Liver fat content, change•Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07441252
Org study ID20230224

Timeline

Milestones

Study first posted2026-02-27actual
Study start2026-03-05actual
Last update posted2026-05-22actual
Primary completion2027-09-29estimated
Study completion2027-12-22estimated

Assets

Investigational agents

Maridebart cafraglutide / MariTide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age99 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Age ≥ 18 years.
•Body Mass index (BMI) ≥ 27 kg/m^2 to ≤ 40 kg/m^2 at screening.
•For participants with type 2 diabetes mellitus (T2DM) at screening:
•HbA1c ≤ 9.5% (80 mmol/mol) at screening.
•Treated with diet and exercise alone and/or a stable treatment with metformin, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, or combination.
•Liver Controlled Attenuation Parameter (CAPTM) ≥ 300 dB/meter via FibroScan® assessment.
•Liver fat content ≥ 10% by MRI as determined by the central imaging vendor at screening.
•MRI assessment should only be performed after all other eligibility has been confirmed whenever possible.
•History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.

Exclusion criteria

•Recent or planned surgical/device-based obesity treatment (<1 year).
•History of malignancy within the past 5 years (exceptions apply).
•Type 1 diabetes or non-type 2 diabetes mellitus (T2DM); unstable/severe hypoglycemia.
•Advanced diabetic retinopathy or macular edema.
•History of pancreatitis (acute <180 days or chronic).
•History of medullary thyroid carcinoma (MTC) or MEN-2
•Major cardiovascular event within 60 days (e.g., myocardial infarction [MI], stroke, coronary artery bypass graft [CABG]).
•New York Heart Association (NYHA) Class IV heart failure.
•Unstable psychiatric disorders within 2 years.
•Significant liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD) (e.g., hepatitis, cirrhosis, hepatic decompensation).
•Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2 or on dialysis.
•Patient Health Questionnaire-9 (PHQ-9) ≥ 15, or suicidal ideation/behavior (Columbia-Suicide Severity Rating Scale [C-SSRS]).
•Inability to undergo MRI scan (e.g., due to metal implant, claustrophobia, or body size limitations).

Endpoints (25)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

MASH / liver
10
Weight & body composition
9
Glycemic / diabetes
3
Safety / tolerability / PK
3

Weight & body composition

9 endpoints
Primary/protocol endpoint

Percent Change from Baseline in Body Weight at Week 52

Time frame:Baseline and Week 52

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Visceral Adipose Tissue (VAT) Volume by MRI at Week 52

Time frame:Baseline and Week 52

Visceral fat, change

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percent Change from Baseline in Thigh Muscle Volume by MRI at Week 24 and Week 52

Time frame:Baseline, Week 24, and 52

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Thigh Muscle Fat Fraction by MRI at Week 24 and Week 52

Time frame:Baseline, Week 24, and 52

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Thigh Intermuscular and Intramuscular Fat Volume by MRI at Week 24 and Week 52

Time frame:Baseline, Week 24, and 52

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Abdominal Subcutaneous Adipose Tissue (ASAT) Volume by MRI at Week 52

Time frame:Baseline and Week 52

Subcutaneous fat, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in VAT Volume by MRI at Week 24

Time frame:Baseline and Week 24

Visceral fat, change

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference at Week 52

Time frame:Baseline and Week 52

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist-to-height Ratio at Week 52

Time frame:Baseline and Week 52

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Change from Baseline in Hemoglobin A1c (HbA1c) at Week 52

Time frame:Baseline and Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline in Fasting Glucose at Week 52

Time frame:Baseline and Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Percent Change from Baseline in Fasting Insulin at Week 52

Time frame:Baseline and Week 52

percent change from baseline, improvement

MASH / liver

10 endpoints
Primary/protocol endpoint

Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) at Week 52

Time frame:Baseline and Week 52

Liver fat content, change

percent change from baseline, improvement

Secondary/protocol endpoint

Number of Participants Achieving ≥ 30% Reduction from Baseline in Liver Fat Content (LFC) by MRI at Week 52

Time frame:Baseline and Week 52

MRI-PDFF ≥30% responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Achieving < 5% LFC by MRI at Week 52

Time frame:Week 52

Liver fat content, change

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in LFC by MRI at Week 52

Time frame:Baseline and Week 52

Liver fat content, change

change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in LFC by MRI at Week 24

Time frame:Baseline and Week 24

Liver fat content, change

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in LFC by MRI at Week 24

Time frame:Baseline and Week 24

Liver fat content, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percent Change from Baseline in ASAT Volume by MRI at Week 24

Time frame:Baseline and Week 24

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Aspartate Aminotransferase (AST) at Week 52

Time frame:Baseline and Week 52

AST, change

change from baseline, improvement

LOINC 1920-8

Secondary/protocol endpoint

Change from Baseline in Alanine Aminotransferase (ALT) at Week 52

Time frame:Baseline and Week 52

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Change from Baseline in Gamma Glutamyl Transferase (GGT) at Week 52

Time frame:Baseline and Week 52

γ-GT, change

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Plasma Concentration of Maridebart Cafraglutide at Week 52

Time frame:Week 52

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Number of Participants Experiencing Treatment-emergent adverse events (TEAEs)

Time frame:From first dose to end of trial (up to approximately 65 weeks)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants Experiencing Serious AEs (SAEs)

Time frame:From screening to end of trial (up to approximately 69 weeks)

Serious AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.